Desoximetasone 0.05% Cream 60gm

Manufacturer LUPIN Active Ingredient Desoximetasone Cream, Gel, and Ointment(des oks i MET a sone) Pronunciation des oks i MET a sone
It is used to treat skin irritation.It is used to treat skin rashes.
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Drug Class
Corticosteroid, Topical
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Pharmacologic Class
Adrenocortical steroid, synthetic; Glucocorticoid
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Pregnancy Category
Category C
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FDA Approved
Aug 1977
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DEA Schedule
Not Controlled

Overview

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What is this medicine?

Desoximetasone is a strong corticosteroid cream used on the skin to reduce redness, swelling, and itching caused by skin conditions like eczema or psoriasis. It works by calming down the immune response in the skin.
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How to Use This Medicine

Using Your Medication Correctly

To use this medication safely and effectively, follow your doctor's instructions carefully. Read all the information provided to you and follow the instructions precisely. Continue using the medication as directed, even if your symptoms improve.

Applying the Medication

Do not take this medication by mouth. It is for topical use on your skin only.
Avoid getting the medication in your mouth, nose, or eyes, as it may cause burning.
Do not apply the medication to the vagina.
Wash your hands before and after applying the medication, unless your hand is the treated area. In that case, do not wash your hand after application.
Clean the affected area before applying the medication and dry it thoroughly.
Apply a thin layer of the medication to the affected skin and gently rub it in.

Important Application Instructions

Do not cover the treated area with bandages or dressings unless your doctor instructs you to do so.

Storing and Disposing of Your Medication

Store the medication at room temperature.
Keep all medications in a safe place, out of the reach of children and pets.
Dispose of unused or expired medications properly. Do not flush them down the toilet or pour them down the drain unless instructed to do so by your pharmacist. Check with your pharmacist for guidance on the best way to dispose of medications, and consider participating in a drug take-back program in your area.

Missing a Dose

If you miss a dose, apply it as soon as you remember.
If it is close to the time for your next dose, skip the missed dose and resume your regular application schedule.
* Do not apply two doses at the same time or use extra doses to make up for a missed dose.
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Lifestyle & Tips

  • Wash hands before and after applying the cream.
  • Apply a thin layer only to the affected skin areas as directed by your doctor.
  • Do not use more than the prescribed amount or for longer than recommended.
  • Avoid applying to the face, groin, or armpits unless specifically instructed by your doctor.
  • Do not use with occlusive dressings (e.g., bandages, plastic wrap) unless directed by your doctor, as this can increase absorption.
  • Avoid contact with eyes. If contact occurs, rinse thoroughly with water.
  • Keep out of reach of children.

Dosing & Administration

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Adult Dosing

Standard Dose: Apply a thin film to the affected skin areas twice daily.

Condition-Specific Dosing:

psoriasis: Apply a thin film to the affected skin areas twice daily.
eczema: Apply a thin film to the affected skin areas twice daily.
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Pediatric Dosing

Neonatal: Not established
Infant: Not established (use with caution, increased risk of systemic effects)
Child: Apply a thin film to the affected skin areas twice daily. Use with caution, for shortest duration possible, and least potent effective dose due to higher risk of systemic absorption and HPA axis suppression.
Adolescent: Apply a thin film to the affected skin areas twice daily.
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Dose Adjustments

Renal Impairment:

Mild: No specific adjustment needed for topical use.
Moderate: No specific adjustment needed for topical use.
Severe: No specific adjustment needed for topical use.
Dialysis: No specific adjustment needed for topical use.

Hepatic Impairment:

Mild: No specific adjustment needed for topical use.
Moderate: No specific adjustment needed for topical use.
Severe: No specific adjustment needed for topical use.

Pharmacology

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Mechanism of Action

Desoximetasone is a synthetic corticosteroid that possesses anti-inflammatory, antipruritic, and vasoconstrictive properties. Its primary mechanism of action involves binding to glucocorticoid receptors in the cytoplasm, leading to the formation of a steroid-receptor complex. This complex translocates to the nucleus, where it modulates gene expression by binding to specific DNA sequences (glucocorticoid response elements). This modulation results in the synthesis of anti-inflammatory proteins (e.g., lipocortins) and inhibition of pro-inflammatory mediators (e.g., prostaglandins, leukotrienes, cytokines), thereby reducing inflammation, edema, and pruritus.
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Pharmacokinetics

Absorption:

Bioavailability: Variable (depends on skin integrity, vehicle, duration of exposure, and use of occlusive dressings). Systemic absorption is generally low but can increase significantly with damaged skin, prolonged use, or occlusive dressings.
Tmax: Not applicable for topical absorption leading to systemic effects, as peak systemic levels are highly variable and often negligible.
FoodEffect: Not applicable (topical administration).

Distribution:

Vd: Not available (primarily local action)
ProteinBinding: Not available (primarily local action, but systemically absorbed corticosteroids bind extensively to plasma proteins, mainly albumin and corticosteroid-binding globulin)
CnssPenetration: Limited (systemic absorption is low)

Elimination:

HalfLife: Not precisely determined for topical application due to variable absorption; systemically absorbed corticosteroids have variable half-lives.
Clearance: Not available (primarily local action)
ExcretionRoute: Renal (primarily via urine) and biliary (via feces) for systemically absorbed drug.
Unchanged: Not available
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Pharmacodynamics

OnsetOfAction: Within hours to days for anti-inflammatory and antipruritic effects.
PeakEffect: Variable, depends on the condition and individual response.
DurationOfAction: Variable, typically requires twice-daily application for sustained effect.

Safety & Warnings

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Side Effects

Urgent Side Effects: Seek Medical Help Right Away

While rare, some people may experience severe and potentially life-threatening side effects when taking this medication. If you notice any of the following symptoms, contact your doctor or seek medical attention immediately:

Signs of an allergic reaction, such as:
+ Rash
+ Hives
+ Itching
+ Red, swollen, blistered, or peeling skin with or without fever
+ Wheezing
+ Tightness in the chest or throat
+ Trouble breathing, swallowing, or talking
+ Unusual hoarseness
+ Swelling of the mouth, face, lips, tongue, or throat
Signs of a weak adrenal gland, including:
+ Severe upset stomach or vomiting
+ Severe dizziness or fainting
+ Muscle weakness
+ Feeling extremely tired
+ Mood changes
+ Decreased appetite
+ Weight loss
Signs of Cushing's syndrome, such as:
+ Weight gain in the upper back or belly
+ Moon face
+ Severe headache
+ Slow healing
Signs of high blood sugar, including:
+ Confusion
+ Feeling sleepy
+ Unusual thirst or hunger
+ Frequent urination
+ Flushing
+ Fast breathing
+ Breath that smells like fruit
Skin changes, such as:
+ Pimples
+ Stretch marks
+ Slow healing
+ Hair growth
Thinning of the skin
Changes in eyesight

Other Possible Side Effects

Like all medications, this drug can cause side effects. Many people experience no side effects or only mild ones. If you notice any of the following side effects or any other unusual symptoms, contact your doctor or seek medical attention if they bother you or do not go away:

Burning, itching, dryness, or other irritation at the application site

Reporting Side Effects

This list is not exhaustive, and you may experience other side effects. If you have questions or concerns about side effects, contact your doctor. You can also report side effects to the FDA at 1-800-332-1088 or online at https://www.fda.gov/medwatch.
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Seek Immediate Medical Attention If You Experience:

  • Severe burning, itching, or irritation where the cream is applied.
  • New skin infections (e.g., pus, redness, warmth).
  • Thinning of the skin, stretch marks, or changes in skin color.
  • Signs of systemic absorption: unusual tiredness, weakness, nausea, vomiting, dizziness, swelling in ankles/feet, increased thirst or urination, blurred vision.
  • Worsening of your skin condition or no improvement after 2 weeks.
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Before Using This Medicine

Before Taking This Medication: Important Information to Share with Your Doctor

It is essential to inform your doctor about the following:

Any allergies you have, including allergies to this medication, its components, or other substances, such as foods or drugs. Be sure to describe the symptoms you experienced as a result of the allergy.
All medications you are currently taking, including prescription and over-the-counter (OTC) drugs, natural products, and vitamins. This is crucial because this medication may interact with other drugs or exacerbate existing health problems.
* Any health issues you are experiencing, as they may affect the safety and efficacy of this medication.

To ensure your safety, it is vital to verify that it is safe to take this medication in conjunction with all your other medications and health conditions. Never start, stop, or modify the dosage of any medication without first consulting your doctor.
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Precautions & Cautions

It is essential to inform all your healthcare providers, including doctors, nurses, pharmacists, and dentists, that you are taking this medication.

When applying this medication to the diaper area, avoid using tight-fitting diapers or plastic pants, as this can increase the amount of medication absorbed into the body.

Before using any other medications or products on your skin, including soaps, consult with your doctor to ensure safe use.

Do not apply this medication to cuts, scrapes, or damaged skin. Exercise caution when applying it to large areas of skin or near open wounds, and discuss any concerns with your doctor.

Use this medication only for the duration prescribed by your doctor. Do not exceed the recommended treatment period.

Be aware that this medication may increase the risk of developing cataracts or glaucoma. Discuss this potential risk with your doctor.

In children and teenagers, this medication may affect growth in some cases. Regular growth checks may be necessary, so consult with your doctor to monitor growth and development.

When using this medication in children, exercise caution, as the risk of certain side effects may be higher in this age group.

If you are pregnant, plan to become pregnant, or are breastfeeding, inform your doctor to discuss the potential benefits and risks to you and your baby.

If you are breastfeeding, avoid applying this medication to your chest. Instead, consult with your doctor for guidance on safe use.
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Overdose Information

Overdose Symptoms:

  • Prolonged or excessive use can lead to systemic effects of corticosteroids, including Cushing's syndrome (e.g., moon face, buffalo hump, central obesity, thin skin, easy bruising), hyperglycemia, and HPA axis suppression.

What to Do:

Discontinue the medication gradually under medical supervision. Symptomatic and supportive treatment. Call 1-800-222-1222 (Poison Control).

Drug Interactions

Monitoring

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Baseline Monitoring

Skin condition assessment

Rationale: To establish baseline severity of dermatosis and identify areas for application.

Timing: Prior to initiation of therapy.

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Routine Monitoring

Local skin reactions (e.g., atrophy, striae, telangiectasias, burning, itching, irritation, folliculitis, acneiform eruptions, hypopigmentation)

Frequency: Regularly during treatment, especially with prolonged use.

Target: Absence of severe reactions.

Action Threshold: If severe reactions occur, discontinue use and reassess.

Signs of HPA axis suppression (e.g., fatigue, weakness, nausea, vomiting, hypotension, weight loss)

Frequency: Periodically, especially with prolonged use, large surface area application, or occlusive dressings.

Target: Normal HPA axis function.

Action Threshold: If suspected, perform ACTH stimulation test or plasma cortisol levels. Discontinue or taper if suppression is confirmed.

Intraocular pressure (if applied near eyes)

Frequency: Periodically, especially with prolonged use near eyes.

Target: Normal intraocular pressure.

Action Threshold: If elevated, consult ophthalmologist.

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Symptom Monitoring

  • Worsening of skin condition
  • New skin lesions or infections
  • Excessive burning, itching, or irritation at application site
  • Signs of systemic absorption: unexplained fatigue, weakness, nausea, vomiting, dizziness, weight loss, swelling in ankles/feet, increased thirst/urination (hyperglycemia)

Special Patient Groups

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Pregnancy

Use during pregnancy only if the potential benefit justifies the potential risk to the fetus. Animal studies have shown teratogenic effects with corticosteroids. Systemic absorption is possible.

Trimester-Specific Risks:

First Trimester: Potential for teratogenicity, though data for topical corticosteroids are limited. Avoid if possible.
Second Trimester: Risk generally considered lower than first trimester, but still use with caution.
Third Trimester: Risk generally considered lower than first trimester, but still use with caution. Potential for HPA axis suppression in the neonate with extensive maternal use.
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Lactation

It is not known whether topical administration of corticosteroids could result in sufficient systemic absorption to produce detectable quantities in breast milk. Use with caution. Avoid applying to the breast area to prevent infant ingestion.

Infant Risk: Low risk with limited, short-term use. Potential for systemic effects in infant if significant absorption occurs or if applied to breast and ingested.
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Pediatric Use

Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic adverse effects, including HPA axis suppression and Cushing's syndrome. Use the least potent effective dose for the shortest duration possible. Monitor growth and development.

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Geriatric Use

No specific dosage adjustments are typically needed. However, elderly patients may have thinner skin, which could potentially increase systemic absorption and susceptibility to local adverse effects (e.g., skin atrophy). Use with caution and monitor for adverse effects.

Clinical Information

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Clinical Pearls

  • Desoximetasone is a high-potency topical corticosteroid; use should be limited to short-term treatment of severe dermatoses.
  • Avoid prolonged use, especially on the face, intertriginous areas, or in children, due to increased risk of skin atrophy, telangiectasias, and systemic absorption.
  • Educate patients on proper application technique: apply a thin film, rub in gently, and wash hands after use.
  • If no improvement is seen after 2 weeks, reassess the diagnosis and treatment plan.
  • Be vigilant for signs of HPA axis suppression, especially in pediatric patients or with extensive/occlusive use.
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Alternative Therapies

  • Other topical corticosteroids (e.g., clobetasol, betamethasone, triamcinolone, fluocinolone, hydrocortisone) varying in potency.
  • Topical calcineurin inhibitors (e.g., tacrolimus, pimecrolimus) for eczema.
  • Vitamin D analogs (e.g., calcipotriene) for psoriasis.
  • Systemic therapies (e.g., biologics, methotrexate, cyclosporine) for severe, widespread conditions.
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Cost & Coverage

Average Cost: $50 - $200 per 60gm tube
Generic Available: Yes
Insurance Coverage: Tier 1 or 2 (generic), Tier 3 (brand)
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General Drug Facts

If your symptoms or health issues persist or worsen, it is essential to contact your doctor for further guidance. To ensure your safety, never share your medication with others or take someone else's medication. Some medications may come with an additional patient information leaflet, so it's a good idea to check with your pharmacist. If you have any questions or concerns about this medication, don't hesitate to discuss them with your doctor, nurse, pharmacist, or other healthcare provider. In the event of a suspected overdose, immediately call your local poison control center or seek emergency medical attention. When seeking help, be prepared to provide detailed information about the overdose, including the medication taken, the amount, and the time it occurred.